Parenteral container



Sept. 26, 1967 D. BELLAMY, JR 3,343,541

PARENTERAL CONTAINER Filed Jan. 8, 1964 INVENTOR. DAVID BELLAMY JR.

MP by ATTORNEY United States Patent 3,343,541 PARENTERAL CONTAINER DavidBellamy, Jr., Glenview, 11]., assignor to Baxter Laboratories, 1120.,Morton Grove, 111., a corporation of Delaware Filed Jan. 8, 1964, Ser.No. 336,569 1 Claim. (Cl. 128-272) The present invention relates to aparenteral solution container provided with a tamper proof closure. Moreparticularly, it relates to a plastic parenteral solution container witha closure structure which provides for a sterile port means and asterile zone about the port means.

Various attempts have been made to prepare a plastic parenteral solutionbag with a tamper proof closure. For the most part these attempts havecomprised placing a rubber stopper in the opening of the outlet port andattaching a tamper proof metal collar to the port or embedding theentire port structure and stopper in plastic. Such closure systems,although they are tamper proof, possess several disadvantages. First,they are diflicult and uneconomic-a1 to assemble; second, they aredifficult to disassemble without violating the sterility of the port;and third, even though the port itself is sterile often the areaimmediately surrounding the port becomes highly contaminated andpresents a hazard which can lead to contamination of the port structureand the contents of the solution container.

It is an object of the present invention to provide a closure structurefor a plastic solution bag which is tamper proof, easy to assemble anddisassemble, and furthermore, provides a sterile zone about the port.

This and still other objects and advantages will be apparent from thedescription which follows.

It has now been discovered that a plastic solution container with asuperior tamper proof closure may be prepared by sealing a section ofrelatively thin tearable plastic film to the container about andsurrounding the port area. The tearable film is preferably provided withtab means for rupturing said film to expose the port area. The tab meansmay be a relatively thicker plastic film which is sealed to the tearablefilm within the periphery of the seal which attaches the tearable filmto the bag.

In further describing the invention reference will be had to thedrawings in which:

FIGURE 1 is an elevational view showing one embodiment of the noveltamper proof closure of the present invention.

FIGURE 2 is a sectional view taken along lines 2-2 of FIGURE 1 showingthe details of the port and closure structure.

FIGURE 3 is an elevational view of the embodiment of FIGURE 1 showingthe method of exposing the sterile port area.

In FIGURE 1 is seen a plastic solution container 10 provided with hangermeans 11, port 12, and a tamper proof protective closure for said portgenerally referred to as 13. As seen in FIGURES 1 and 2, the protectiveclosure 13 comprises a section of relatively thin film 14 which isattached to the solution container 10 by a seal 15 about its periphery.Within the periphery of the seal lies the port structure 12. Attached tothe tearable film 14 is a section of relatively thick film 16 which isunited to the tearable film by a seal 17 which lies within the areabounded by the seal 15. As seen in FIGURE 2, the seal 17 is spaced infrom the boundaries of the seal 15 thus creating the tab means 18. Thetab means 18 are adapted to be grasped as shown in FIGURE 3 andmanipulated to expose the port and the adjacent sterile area. To further facilitate the removal or the tearing of the tearable film 14 theseal 17 may be shaped as shown in FIGURES 3,343,541 Patented Sept. 26,1967 l and 3. If desired, additional ports may be included within thesterile zone. For example, a second port which is provided with aresealable stopper might be included to provide for the administrationof supplemental medication.

In the preferred embodiment of the present invention, the bag 10 isformed of polyvinylchloride resin or a laminate thereof; the section oftearable film 14 is formed of a relatively thin polyvinylchloride resinfilm about 0.006 inch thick, and the section of relatively thick film 16is formed of polyvinylchloride resin film about 0.015 inch thick. Ifdesired the tab means 18 may be ribbed or otherwise modified to providea secure gripping surface (as seen in FIGURE 3). The use of thepolyvinylchloride resin for all three components is preferred because ofthe ease with which components formed of that resin may be sealed toeach other.

If desired, the novel tamper proof closure may be sealed to thecontainer immediately after the container has been filled with solution.However, in a completely automated operation in which the solution bagis simultaneously formed, filled and sterilized, it may be desirable tohave the tamper proof closure already attached to one of the sheets ofplastic which will eventually form a wall of the container. If such isthe case the tamper proof closure and the zone it protects might besterilized separately as by gas sterilization or sterilized with the bagand its contents by any conventional sterilization technique.

In the embodiment illustrated in the drawings a sterile zone is providedonly in the area immediately adjacent the port structure, however, itmay in some circumstances be desirable to more or less completelyenclose the side of the solution bag within the tamper proof protectiveclosure. For example, if desired, a parenteral solution administrationset may be integrally connected to the bag and completely enclosedwithin the novel tamper proof closure system of the present invention.This method of construction would provide substantial advantages formilitary use where a single sterile compact unit for parenteraladministration is desired. In such a case the sterile zone providedwould have to be much larger than that required when a separateunconnected administration set is to "be employed. The integralparenteral solution administration set referred to is a modified outletport and is intended to be covered by the term port as used herein.

It may also be desirable for the tearable film 14 to be provided withprinted directions as to method of use, description of the contents,etc., thereby eliminating the necessity of printing such data directlyupon the wall of the parenteral solution container. This has theadvantage of effectively protecting against the migration of any of theingredients of the printing materials through the wall of the containerand into the parenteral solution.

While in the preferred practice, the films to be employed have beendescribed as being of polyvinylchloride resin it will be understood thatother plastics which are equivalent to the polyvinylchloride resin forthis particular use such as polyolefin resins, polyhalocarbon resins andthe like may be used and are intended to be covered by the termpolyvinylchloride resin as used herein.

It will be further understood that the tamper proof clo sure of thepresent invention may be sealed to the parenteral solution bag by heatsealing, dielectric sealing, ultrasonic sealing, gluing or any othersuitable means.

It will be readily apparent to those skilled in the art that the presentinvention provides many substantial advantages over the practice of theprior art. Some of these advantages have been described, still otherswill be apparent to those skilled in the art.

What I claim is:

In a plastic solution bag for containing a sterile par- M enteralsolution and provided with port means including a tubular extensionthrough the wall of said bag, a tamper proof closure for said port meanscomprising a relatively thin tearable plastic film permanently sealed tosaid hag around its edges and encompassing a sterile zone, said portmeans being located within said sterile zone, tab means for rupturingsaid tearable plastic film to expose the sterile zone and port means,said tab means including a relatively thick tear tab being locatedwithin the periphery of the seal which joins the thin plastic film tothe bag.

References Cited UNITED STATES PATENTS Cherkin 128-272 Spees 229-51Flynn 128-214 Spees.

Cocoran et a1 128-272 Barton et al. 128-272 X 10 RICHARD A. GAUDET,Primary Examiner.

DALTON L. TRULUCK, Examiner.

